Study to Evaluate MEDI-507 in Patients With CD2-Positive Lymphoma/Leukemia - Full Text View

Sponsored by:	MedImmune LLC
Information provided by:	MedImmune LLC
ClinicalTrials.gov Identifier:	NCT00105313

Purpose

For primary objectives, we will determine the MTD and examine clinical responses and immune cell populations to determine an OBD, and describe the safety and tolerability of MEDI-507.

For the secondary objectives we will look at the antitumor activity of MEDI 507, PK, serum concentrations, and immunogenicity of MEDI-507, as well as time courses of depletion and recovery of CD2 positive and total T-Cell populations.

Condition	Intervention	Phase
Lymphoma Leukemia Cancer	Drug: MEDI-507	Phase I

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma

Drug Information available for: Siplizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase I Open-Label Dose Escalation Study to Evaluate MEDI-507 in Patients With CD2-Positive Lymphoma/Leukemia

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:

To determine the maximum tolerated dose (MTD) or the optimal biological dose
(OBD) of MEDI-507 based on safety and tolerability of MEDI-507 in patients with
CD-2 positive lymphoproliferative disorders.

Estimated Enrollment:	80
Study Start Date:	February 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Individuals may be eligible for this study if they are 18 years of age or older and:

Have one of the following types of T-Cell Lymphoproliferative disorders such as Cutaneous T-cell Lymphoma (CTCL), Peripheral T-cell Lymphoma (PCTL), Large Cell Lymphoma (LGL), or Adult T-cell Lymphoma (ATL). Patients should have disease that is resistant or refractory to the front-line therapy, except ATL patients for whom there is no standard therapy.
At least 30% of tumor cells must be CD2 positive.
Karnofsky Performance status of greater than or equal to 70% (able to care for themselves; but unable to carry on normal activity or to do active work).
At least 3 weeks must have passed since prior systemic cytotoxic chemotherapy, prolonged or cytolytic steroid therapy or major surgery, and all treatment-related toxicities must have resolved prior to the first MEDI-507 administration (except thrombocytopenia).
Have no prior treatment with MEDI-507.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00105313

Locations

United States, California
USC/Norris Cancer Center
Los Angeles, California, United States, 90033
United States, Connecticut
Yale Cancer Center
New Haven, Connecticut, United States, 06520
United States, District of Columbia
Georgetown University Medical Center, Lombardi Comprehensive Cancer Center
Washington, District of Columbia, United States, 20007
United States, Florida
H. Lee Moffitt Cancer Ctr & Research Institute Div of Hem/Onc
Tampa, Florida, United States, 33612
United States, Maryland
University of Maryland School of Medicine, Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Tufts New England Medical Center
Boston, Massachusetts, United States, 02111
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27517
United States, Pennsylvania
Kimmel Cancer Center, Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

MedImmune LLC

Investigators

Study Director:

Luz Hammershaimb, MD

MedImmune LLC

More Information

Study ID Numbers:	MI-CP107
Study First Received:	March 11, 2005
Last Updated:	June 12, 2007
ClinicalTrials.gov Identifier:	NCT00105313
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Lymphatic Diseases
Leukemia
Immunoproliferative Disorders
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009